Siemens Healthineers · 8 hours ago
Product Development Scientist - Remote
United States
Full-time
Remote
Mid, Senior Level
$105K/yr - $144K/yr
3+ years expSiemens Healthineers is a leader in medical technology, pioneering breakthroughs in healthcare. They are seeking a Product Development Scientist to support product and process development for intravascular medical devices, focusing on preclinical studies and regulatory submissions.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Support studies to characterize products and processes related to product development of implantable intravascular therapies
Design and conduct studies (pre-clinical, in vivo, in vitro, analytical) to assess new products and product applications
Coordinate pre-clinical study tasks from study initiation to study completion
Manage contracting with third party vendors including the development of timelines and cost estimates for preclinical tasks
Develop protocols and final reports associated with pre-clinical work to support regulatory submissions for new designs or product improvements
Develop and execute complex test plans involving significant data collection and interpretation, assessment of results, and incorporation of step for continuous design improvements
Lead collaborations with toxicologists and pre-clinical experts to develop biocompatibility assessments based on ISO-10993 requirements
Collaborate with regulatory affairs teams to write pre-submissions and full submissions for FDA 510(k) and/or PMA medical devices processes
Collaborate with product development engineering to perform design verification and validation activities
Collaborate with product development engineering to develop and maintain use risk hazard analyses, design failure modes and effects analyses, and other product risk documentation
Write technical documentation including process descriptions and test methods
Contribute to and maintain FDA compliant Design History Files (DHF)
Execute process improvements as they relate to quality system compliance with FDA 510(k), QSR and ISO 13485
Perform other duties as assigned or required
Qualification
Required
BS in Biology, Biomedical Engineering, or related field
3+ years of scientific or engineering experience with preference to experience in medical device or other regulated industry
Experience in the development and qualification of pre-clinical studies is required
Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry
Working knowledge of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)
Experience with design verification & validation
Able to define and develop test procedures and to perform design verification
Preferred
MS or PhD preferred
5+ years is preferred
Experience working within a company's Quality System is preferred
Experience in FDA pre-submission and submission preparation is preferred
Experience in the development of regulated medical devices or combination products is preferred
Experience in veterinary surgery is a plus
Experience with interventional radiology or brachytherapy-related studies is preferred, including x-ray imaging and pre-clinical animal models
Experience with biocompatibility ISO-10993 testing and requirements for implantable devices is preferred
Experience in clinical and pre-clinical study workflow for embolic, radioembolic, or brachytherapy procedures is preferred
Knowledge of laboratory techniques such as chemical analysis (XRD, DSC, sizing, FTIR) and mechanical analysis is a plus
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term and short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Sebastian Kronmueller
Vice President, Head of Strategy & Business Development - Laboratory Diagnostics
Recent News
2026-01-16
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